Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.

<h4>Background</h4>This study aimed to assess the comparability among assays using freshly frozen human sera and external quality assessment (EQA) data in China.<h4>Methods</h4>Twenty-nine serum samples and two commercial EQA materials, obtained from the National Center for C...

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Autores principales: Shunli Zhang, Fei Cheng, Hua Wang, Jiangping Wen, Jie Zeng, Chuanbao Zhang, Wensong Liu, Ning Wang, Tingting Jia, Mo Wang, Rui Zhang, Yuhong Yue, Jing Xu, Zhanyong Wang, Yilong Li, Wenxiang Chen, Qingtao Wang
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Publicado: Public Library of Science (PLoS) 2021
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spelling oai:doaj.org-article:24a9bfb4cf844afc842d90a2ec8556792021-12-02T20:10:37ZComparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.1932-620310.1371/journal.pone.0253324https://doaj.org/article/24a9bfb4cf844afc842d90a2ec8556792021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0253324https://doaj.org/toc/1932-6203<h4>Background</h4>This study aimed to assess the comparability among assays using freshly frozen human sera and external quality assessment (EQA) data in China.<h4>Methods</h4>Twenty-nine serum samples and two commercial EQA materials, obtained from the National Center for Clinical Laboratories (NCCL), were analyzed in triplicate using eight routine TSH assays. The commutability of commercial EQA materials (NCCL materials) was evaluated in accordance with the CLSI EP30-A and IFCC bias analysis. Median values obtained for the NCCL EQA materials were used to determine the systematic and commutability-related biases among immunoassays through back-calculation. The comparability of TSH measurements from a panel of clinical samples and NCCL EQA data was determined on the basis of Passing-Bablok regression. Furthermore, human serum pools were used to perform commutable EQA.<h4>Results</h4>NCCL EQA materials displayed commutability among three or five of seven assay combinations according CLSI or IFCC approach, respectively. The mean of systematic bias ranged from -13.78% to 9.85% for the eight routine TSH assays. After correcting for systematic bias, averaged commutability-related biases ranged between -42.26% and 12.19%. After correction for systematic and commutability -related biases, the slopes indicating interassay relatedness ranged from 0.801 to 1.299 using individual human sera, from 0.735 to 1.254 using NCCL EQA data, and from 0.729 to 1.115 using pooled human serum EQA(the commutable EQA).<h4>Conclusions</h4>The harmonization of TSH measurement is challenging; hence, systematic and commutability-related biases should be determined and corrected for accurate comparisons among assays when using human individual serum and the commercial EQA materials.Shunli ZhangFei ChengHua WangJiangping WenJie ZengChuanbao ZhangWensong LiuNing WangTingting JiaMo WangRui ZhangYuhong YueJing XuZhanyong WangYilong LiWenxiang ChenQingtao WangPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 6, p e0253324 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Shunli Zhang
Fei Cheng
Hua Wang
Jiangping Wen
Jie Zeng
Chuanbao Zhang
Wensong Liu
Ning Wang
Tingting Jia
Mo Wang
Rui Zhang
Yuhong Yue
Jing Xu
Zhanyong Wang
Yilong Li
Wenxiang Chen
Qingtao Wang
Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.
description <h4>Background</h4>This study aimed to assess the comparability among assays using freshly frozen human sera and external quality assessment (EQA) data in China.<h4>Methods</h4>Twenty-nine serum samples and two commercial EQA materials, obtained from the National Center for Clinical Laboratories (NCCL), were analyzed in triplicate using eight routine TSH assays. The commutability of commercial EQA materials (NCCL materials) was evaluated in accordance with the CLSI EP30-A and IFCC bias analysis. Median values obtained for the NCCL EQA materials were used to determine the systematic and commutability-related biases among immunoassays through back-calculation. The comparability of TSH measurements from a panel of clinical samples and NCCL EQA data was determined on the basis of Passing-Bablok regression. Furthermore, human serum pools were used to perform commutable EQA.<h4>Results</h4>NCCL EQA materials displayed commutability among three or five of seven assay combinations according CLSI or IFCC approach, respectively. The mean of systematic bias ranged from -13.78% to 9.85% for the eight routine TSH assays. After correcting for systematic bias, averaged commutability-related biases ranged between -42.26% and 12.19%. After correction for systematic and commutability -related biases, the slopes indicating interassay relatedness ranged from 0.801 to 1.299 using individual human sera, from 0.735 to 1.254 using NCCL EQA data, and from 0.729 to 1.115 using pooled human serum EQA(the commutable EQA).<h4>Conclusions</h4>The harmonization of TSH measurement is challenging; hence, systematic and commutability-related biases should be determined and corrected for accurate comparisons among assays when using human individual serum and the commercial EQA materials.
format article
author Shunli Zhang
Fei Cheng
Hua Wang
Jiangping Wen
Jie Zeng
Chuanbao Zhang
Wensong Liu
Ning Wang
Tingting Jia
Mo Wang
Rui Zhang
Yuhong Yue
Jing Xu
Zhanyong Wang
Yilong Li
Wenxiang Chen
Qingtao Wang
author_facet Shunli Zhang
Fei Cheng
Hua Wang
Jiangping Wen
Jie Zeng
Chuanbao Zhang
Wensong Liu
Ning Wang
Tingting Jia
Mo Wang
Rui Zhang
Yuhong Yue
Jing Xu
Zhanyong Wang
Yilong Li
Wenxiang Chen
Qingtao Wang
author_sort Shunli Zhang
title Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.
title_short Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.
title_full Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.
title_fullStr Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.
title_full_unstemmed Comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.
title_sort comparability of thyroid-stimulating hormone immunoassays using fresh frozen human sera and external quality assessment data.
publisher Public Library of Science (PLoS)
publishDate 2021
url https://doaj.org/article/24a9bfb4cf844afc842d90a2ec855679
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